Menopause SyndromePhase 2NCT06385795
A Study of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
A Phase 2 study testing NOE-115 in people with Menopause Syndrome and Menopause, run by Noema Pharma AG at 5 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause Syndrome, Menopause, Hot Flashes
- What is being tested?
- NOE-115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesUnited States
- Study dates
- 22 Apr 2024to 13 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
- Female 45 years to 60 years of age inclusive, at the time of signing the Informed Consent Form
- Women who have experienced changes in menstrual cycle frequency or duration, and/or symptoms that are indicative of menopausal transition, as determined by the investigator
- Greene climacteric scale (GCS) total score > 20 and GCS subscore for VMS ≥ 3
- Over the 10 days prior to enrolment (during the Screening Period), subject has a minimum of 7 to 8 moderate to severe hot flashes (VMS) per day, or 50 to 60 per week
- Body weight > 50 kg; Body Mass Index (BMI) within the range 17.5 to 40.0 kg/m2 (inclusive)
Who cannot join
- Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening).
- History of psychiatric diagnoses (schizophrenia, schizoaffective, obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivity Disorder(ADHD)
- Current episode of major depression with Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 17 [to be calculated as a subscore of the Structured interview guide for the Hamilton depression scale with atypical depression supplement [SIGH-ADS]
- Prior or current history of a malignant tumor, except for basal cell carcinoma in remission
- Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either the patient's safety or the results of the study
- Participant has abnormal findings identified during the Screening Period assessments, including neurological and physical examinations, hematology and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram (ECG), as compared with the appropriate reference ranges; if judged not clinically significant, the PI should document this fact appropriately
Show all 11Show fewer
- History of unexplained uterine bleeding or endometrial hyperplasia
- History of acute angle closure glaucoma
- History of cardiovascular disease including:
- Uncontrolled hypertension (systolic Blood Pressure (BP) > 165 mmHg or diastolic Blood Pressure > 100 mmHg) b) History of myocardial infarction, cardiac arrhythmia (other than sinus arrhythmia) c) Patients with a 12-lead Electrocardiogram (ECG demonstrating either of the following: QT interval corrected for heart rate according to Fridericia's formula (QTcF) ≥ 470 msec (average of 3 Electrocardiograms (ECGs) obtained at the Screening Visit and assessed by central reader) QRS interval > 120 msec at the Screening Visit (local reading) Arrhythmia (other than sinus arrhythmia), conduction abnormalities (Atrioventricular block Grade 1 is allowed)
- Patients who express suicidal ideation or have recent history of suicidal behavior and who, in the opinion of the investigator, are at risk of harming themselves
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Noema PMM-201 Site #101
Atlanta, Georgia, 30030
Noema PMM-201 Site #102
Jacksonville, Florida, 32256
Noema PMM-201 Site #106
Las Vegas, Nevada, 89106
Noema PMM-201 Site #104
San Diego, California, 92111
Noema PMM-201 Site #103
Seattle, Washington, 98105
About this study
Official title: A Phase 2a, 4-Week, Single Arm, Open-label, Multi-center Study to Assess Safety, Tolerability, and Preliminary Efficacy of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.
Read the detailed description
This is a multi-center study to evaluate the effect of NOE-115, a monoamine modulator, in patients with moderate to severe vasomotor symptoms (hot flashes) due to menopause.
Women will participate in the study for a total of approximately 12 weeks, comprising a screening period (4 weeks), treatment period (4 weeks), and a follow up period (4 weeks).
The study is single arm but enrollment will occur in two cohorts. In Cohort, enrolled women will receive NOE-115 at a daily Dose A for the entire 4-week treatment period. Cohort 1 participants will return to the clinic on specified days per protocol for tolerability assessments.
Cohort 2 will enroll participants after the acceptable safety/tolerability of NOE-115 Dose A has been determined from Cohort 1.
Administration of NOE-115 will start on Study Day 1 and will continue daily for 4 weeks and will start at Dose A of NOE-115 as defined by the study protocol. Participants will receive NOE-115 up to a maximum- daily dose based on Investigator decision. Cohort 2 participants will return to the clinic on specified days per protocol for tolerability assessments and possible dose increases of NOE-115.
- Conditions
- Menopause Syndrome, Menopause, Hot Flashes
- Being tested
- NOE-115
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOE-115Drug
NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity.
| Study group | Role | What they receive |
|---|---|---|
| NOE-115 | Experimental | Escalating doses of NOE-115 capsules Receives: Drug: NOE-115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason
Occurrence of withdrawal from the study by the participant due to adverse event. An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study
Measured: 4 weeks
Secondary outcomes (4)
Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)
An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study
Measured: 4 weeks
Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4
Severity of the hot flashes will be assessed by participants using a daily hot flash diary from baseline to Week 4 of the study
Measured: 4 weeks
Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4
Hot flash frequency will be assessed by participants using a daily hot flash diary from baseline to Week 4
Measured: 4 weeks
Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4
The CGI-S rating is based upon observed and reported symptoms, behavior, and function in the past seven days and asks the clinician one question: "Considering your total clinical experience with this particular population, how ill is the patient at this time?" which is rated on the following seven-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start22 Apr 2024
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noema Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Director, MD, Study director, Noema Pharma AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385795
- Sponsor's protocol ID
- NOE-PMM-201
- Status last verified
- Sep 2025
- First submitted
- 15 Apr 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, 4-Week, Single Arm, Open-label, Multi-center Study to Assess Safety, Tolerability, and Preliminary Efficacy of NOE-115 in Women With Vasomotor Symptoms Due to Menopause
- ClinicalTrials.gov ID
- NCT06385795
- Acronym / sponsor ID
- NOE-PMM-201
- Conditions
- Menopause Syndrome, Menopause, Hot Flashes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Noema Pharma AGIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and preliminary effectiveness of NOE-115 on moderate to severe vasomotor symptoms (hot flashes) due to menopause in women.
Detailed description
This is a multi-center study to evaluate the effect of NOE-115, a monoamine modulator, in patients with moderate to severe vasomotor symptoms (hot flashes) due to menopause.
Women will participate in the study for a total of approximately 12 weeks, comprising a screening period (4 weeks), treatment period (4 weeks), and a follow up period (4 weeks).
The study is single arm but enrollment will occur in two cohorts. In Cohort, enrolled women will receive NOE-115 at a daily Dose A for the entire 4-week treatment period. Cohort 1 participants will return to the clinic on specified days per protocol for tolerability assessments.
Cohort 2 will enroll participants after the acceptable safety/tolerability of NOE-115 Dose A has been determined from Cohort 1.
Administration of NOE-115 will start on Study Day 1 and will continue daily for 4 weeks and will start at Dose A of NOE-115 as defined by the study protocol. Participants will receive NOE-115 up to a maximum- daily dose based on Investigator decision. Cohort 2 participants will return to the clinic on specified days per protocol for tolerability assessments and possible dose increases of NOE-115.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOE-115 | Experimental | Drug: NOE-115Escalating doses of NOE-115 capsules |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Capable of giving signed informed consent as described in study protocol which includes compliance with the requirements and restrictions listed in the Informed Consent Form.
- Female 45 years to 60 years of age inclusive, at the time of signing the Informed Consent Form
- Women who have experienced changes in menstrual cycle frequency or duration, and/or symptoms that are indicative of menopausal transition, as determined by the investigator
- Greene climacteric scale (GCS) total score > 20 and GCS subscore for VMS ≥ 3
- Over the 10 days prior to enrolment (during the Screening Period), subject has a minimum of 7 to 8 moderate to severe hot flashes (VMS) per day, or 50 to 60 per week
Key exclusion criteria (11 listed)
- Clinically overt alcohol or drug use disorder (including use of cannabis/cannabinoids within 4 weeks prior to Screening).
- History of psychiatric diagnoses (schizophrenia, schizoaffective, obsessive-compulsive disorder, bipolar disorder, or Attention Deficit/hyperactivity Disorder(ADHD)
- Current episode of major depression with Hamilton Rating Scale for Depression (HAM-D-17) score ≥ 17 [to be calculated as a subscore of the Structured interview guide for the Hamilton depression scale with atypical depression supplement [SIGH-ADS]
- Prior or current history of a malignant tumor, except for basal cell carcinoma in remission
- Participants with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either the patient's safety or the results of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOE-115NOE-115 is an investigational monoamine modulator which has potential anti-inflammatory activity. | Drug | NOE-115 |
Primary outcome
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason
Time frame: 4 weeks
Occurrence of withdrawal from the study by the participant due to adverse event. An AE is defined as any unfavorable and untoward sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment that occurs during the course of the study
4 secondary outcomes
Number of Participants Who Experience at Least One or More Adverse Event and the Severity of the Adverse Events (AEs)
Time frame: 4 weeks
Weekly Mean Change in the Severity of Hot Flashes from Baseline to Week 4
Time frame: 4 weeks
Weekly Mean Change in the Frequency (any severity) of Hot Flashes from Baseline to Week 4
Time frame: 4 weeks
Effect of NOE-115 as Assessed by Clinical Global Impression of Severity (CGI-S) from Baseline to Week 4
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Menopause Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
Coronary Artery Disease (CAD), Menopause
Recruiting
Effects of a Dietary Intervention Based on the Dietary Guidelines for the Brazilian Population on the Reduction of Menopausal Symptoms in Overweight and Obese Women
Menopause, Menopause Hot Flashes
Recruiting
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Menopause Syndrome, Sleep Disturbance
Active, not recruiting
Reexamining Her Cardiovascular Risk - Ottawa WomeN's Longitudinal Cohort Study
Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director, MD study director
Noema Pharma AG
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOE-115 in people with Menopause Syndrome and Menopause, run by Noema Pharma AG at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Withdrawals Due to Adverse Events While on NOE-115 for Any Reason (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.